Lead assembly including a polymer interconnect and methods related thereto
A lead assembly includes a ring component having mechanical coupling features, and at least one polymer component mechanically coupled with the mechanical coupling features of the ring component. Elongate tubing is disposed over the polymer component and is secured with the polymer component.
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This application is a continuation of U.S. application Ser. No. 13/006,156, filed on Jan. 13, 2011, which is a continuation of U.S. patent application Ser. No. 11/468,996, filed on Aug. 31, 2006, now U.S. Pat. No. 7,917,229, which are hereby incorporated herein by reference in their entirety for all purposes.
Additionally, this application is related to U.S. patent application Ser. No. 11/462,479, filed on Aug. 4, 2006, now published as U.S. Publication No. 2008/0046059, entitled “Lead Including A Heat Fused or Formed Lead Body,” assigned to a common assignee, and is hereby incorporated by reference in its entirety for all purposes.
TECHNICAL FIELDLeads for linking medical devices with selected bodily tissue to be sensed or stimulated by such devices. More particularly, but not by way of limitation, this relates to a lead including a polymer interconnect and methods related thereto.
BACKGROUNDLeads represent the electrical link between an implantable medical device (referred to as “IMD”), such as a pacer or defibrillator, and a subject's cardiac or other bodily tissue, which is to be sensed or stimulated. A lead generally includes a lead body that contains one or more electrical conductors extending from a proximal end portion of the lead to an intermediate or distal end portion of the lead. The lead body includes insulating material for covering and electrically insulating the electrical conductors. The proximal end of the lead further includes an electrical connector assembly couplable with the IMD, while the intermediate or distal end portions of the lead include one or more electrodes that may be placed within or near a desired sensing or stimulation site within the body of the subject.
Implantable leads, such as those used for cardiac sensing or stimulation, should have the ability to remain fully assembled and leak resistant despite constant flexing or bending, which may be encountered with each ventricular or atrial contraction of cardiac tissue (within which the lead is implanted or near) or axial forces applied to the lead during implantation, repositioning, or lead extraction. In addition, implantable leads should be designed to resist failure due to extended contact with in vivo bodily fluids, such as blood.
What is needed is a lead having interconnects able to withstand axial forces disposed to the lead. What is further needed is a lead having interconnects that are capable of being manufactured without the use of adhesive.
In the drawings, like numerals describe substantially similar components throughout the several views. The drawings illustrate generally, by way of example, but not by way of limitation, the various embodiments discussed herein.
The following detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the present leads and methods may be practiced. These embodiments, which are also referred to herein as “examples,” are described in enough detail to enable those skilled in the art to practice the present leads and methods. The embodiments may be combined, other embodiments may be utilized or structural and logical changes may be made without departing from the scope of the present leads and methods. It is also to be understood that the various embodiments of the present leads and methods, although different, are not necessarily mutually exclusive. For example, a particular feature, structure or characteristic described in one embodiment may be included within other embodiments. The following detailed description is, therefore, not to be taken in a limiting sense and the scope of the present leads and methods are defined by the appended claims and their legal equivalents.
Among other things, the IMD 102 includes a source of power as well as an electronic circuitry portion. In one example, the electronic circuitry includes microprocessors to provide processing, evaluation, and to determine and deliver electrical shocks or pulses of different energy levels and timing for ventricular defibrillation, cardioversion, or pacing of heart 108 in response to sensed cardiac arrhythmia including fibrillation, tachycardia, or bradycardia. In another example, the IMD 102 is a battery-powered device that senses intrinsic signals of the heart 108 and generates a series of timed electrical discharges.
The lead 104 includes a lead body 202 (
At least one conductor 120 (
The polymer component 130 includes a polymer ring, such as a ring formed of a thermoplastic, such as polyurethane, in an example. The polymer component 130 includes features that allow for the polymer component 130 to be mechanically coupled with the ring component 150 at an interface 132 (
The polymer component 130 is disposed over the ring component 150. The ring component 150, in an option, is a metal component, for example, allowing for the ring component 150 to be used as a distal electrode 152 of the lead 104. In another option, the ring component 150 is formed in whole or in part of a higher melting point polymer (e.g. PEEK). In an option, the ring component 150 includes at least one recess 154, such as an annular recess, allowing for the polymer component to be received therein. Optionally, an inner metal tube 190 is disposed within the ring component 150, as shown in
The ring component 150 includes mechanical coupling and/or anti-torque features, such as the recess 154, allowing for the polymer component 130 to be coupled therewith.
Referring again to
For additional sealing properties, an optional seal(s) 182 can be provided between the polymer component 130 and the ring component 150, as illustrated in
Referring to
In an example illustrated in
In another example, after the polymer component 130 is disposed over the recess 154, tubing 133, for example low density polyethylene or heat shrink tubing, is disposed over the polymer component 130, and is shrunk, for example while heating, to deform the polymer component 130 into the recess 154 of the ring component 150, as shown in
Referring again to
The lead system is further assembled. For example, one or more conductors are disposed within the elongate tubing, for example, by stringing. The one or more conductors are electrically coupled with one or more electrodes, such as the distal electrode ring component.
Advantageously, the joint provided between the ring component, the polymer component, and the elongate tubing can be made relatively quickly, and will not degrade over time, even in a wet environment or within a body.
It is to be understood that the above description is intended to be illustrative, and not restrictive. It should be noted that the above text discusses and figure illustrate, among other things, implantable leads for use in cardiac situations; however, the present leads and methods are not so limited. Many other embodiments and contexts, such as for non-cardiac nerve and muscle situations or for external nerve and muscle situations, will be apparent to those of skill in the art upon reviewing the above description. The scope should, therefore, be determined with reference to the appended claims, along with the full scope of legal equivalents to which such claims are entitled.
Claims
1. A lead assembly comprising:
- a lead body extending from a proximal end portion to a distal end portion, the distal end portion comprising an interconnect including a polymer component mechanically coupled to a ring component having an outer surface, wherein a portion of an inner surface of the polymer component is disposed over and in contact with the outer surface of the ring component at an interface and at least a portion of the outer surface of the ring component at the interface includes a mechanical coupling feature adapted to inhibit the rotation of the polymer component about the ring component;
- at least one conductor extending within the lead body from the proximal end portion in a direction toward the distal end portion; and
- at least one electrode operatively coupled to the at least one conductor.
2. The lead assembly according to claim 1, wherein the outer surface of the ring component is a non-smooth, textured outer surface.
3. The lead assembly according to claim 1, wherein the outer surface is a knurled surface at the interface.
4. The lead assembly according to claim 1, wherein the outer surface is a surface having cross-threads at the interface.
5. The lead assembly according to claim 1, wherein the outer surface is a surface having a plurality of grooves at the interface.
6. The lead assembly according to claim 1, wherein the outer surface of the ring component includes a roughened surface.
7. The lead assembly according to claim 1, wherein the ring component includes a recess adapted to receive the polymer component.
8. The lead assembly according to claim 7, wherein the outer surface of the ring component within the recess includes a plurality of apertures.
9. The lead assembly according to claim 7, wherein the outer surface of the ring component within the recess includes a plurality of slots.
10. The lead assembly according to claim 1, wherein the polymer component comprises an elastomeric thermoplastic polymer.
11. The lead assembly according to claim 10, wherein the elastomeric thermoplastic is a polyurethane.
12. The lead assembly according to claim 1, wherein the outer surface of the ring component includes textured portions adapted such that the polymer component is disposed at least partially into the textured portions.
13. The lead assembly according to claim 1, wherein the outer surface of the ring component includes an aperture adapted such that the polymer component is disposed at least partially through the holes.
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Type: Grant
Filed: Dec 21, 2012
Date of Patent: May 27, 2014
Patent Publication Number: 20130116766
Assignee: Cardiac Pacemakers, Inc. (St. Paul, MN)
Inventors: Paul E. Zarembo (Vadnais Heights, MN), Elliott Rodriguez Roman (Vega Alta, PR)
Primary Examiner: Nicole F Lavert
Application Number: 13/724,788
International Classification: A61N 1/00 (20060101); A61B 5/04 (20060101);